title: Tocilizumab in patients with active rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs or tumor necrosis factor inhibitors: subanalysis of Spanish results of an open-label study close to clinical practice.
abstract: OBJECTIVE
  To analyze the Spanish experience in an international study which evaluated tocilizumab in patients with rheumatoid arthritis (RA) and an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor inhibitors (TNFis) in a clinical practice setting.
  
  
  METHODS
  Subanalysis of 170 patients with RA from Spain who participated in a phase IIIb, open-label, international clinical trial. Patients presented inadequate response to DMARDs or TNFis. They received 8mg/kg of tocilizumab every 4 weeks in combination with a DMARD or as monotherapy during 20 weeks. Safety and efficacy of tocilizumab were analyzed. Special emphasis was placed on differences between failure to a DMARD or to a TNFi and the need to switch to tocilizumab with or without a washout period in patients who had previously received TNFi.
  
  
  RESULTS
  The most common adverse events were infections (25%), increased total cholesterol (38%) and transaminases (15%). Five patients discontinued the study due to an adverse event. After six months of tocilizumab treatment, 71/50/30% of patients had ACR 20/50/70 responses, respectively. A higher proportion of TNFi-naive patients presented an ACR20 response: 76% compared to 64% in the TNFi group with previous washout and 66% in the TNFi group without previous washout.
  
  
  CONCLUSIONS
  Safety results were consistent with previous results in patients with RA and an inadequate response to DMARDs or TNFis. Tocilizumab is more effective in patients who did not respond to conventional DMARDs than in patients who did not respond to TNFis.
authors.affiliation: Servicio de Reumatología, Unidad de Terapias Biológicas, Hospital Universitario de La Princesa, Madrid, España. Electronic address: jalvarogracia@gmail.com.
authors.forename: José M
authors.initials: JM
authors.lastname: Álvaro-Gracia
authors.affiliation: Servicio de Reumatología, Hospital Regional Universitario Carlos Haya, Universidad de Málaga, Málaga, España.
authors.forename: Antonio
authors.initials: A
authors.lastname: Fernández-Nebro
authors.affiliation: Servicio de Reumatología, Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: Alicia
authors.initials: A
authors.lastname: García-López
authors.affiliation: Servicio de Reumatología, Hospital Universitario Virgen de las Nieves, Granada, España.
authors.forename: Manuel
authors.initials: M
authors.lastname: Guzmán
authors.affiliation: Servicio de Reumatología, Complejo Universitario Hospitalario de A Coruña, A Coruña, España.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Blanco
authors.affiliation: Servicio de Reumatología, Hospital Universitario de Elche, Elche, Alicante, España.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Navarro
authors.affiliation: Servicio de Reumatología, Hospital Universitario de Canarias, La Laguna, Tenerife, España.
authors.forename: Sagrario
authors.initials: S
authors.lastname: Bustabad
authors.affiliation: Departamento Médico, Roche, Madrid, España.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Armendáriz
authors.affiliation: Servicio de Reumatología, Hospital Universitario La Fe, Valencia, España.
authors.forename: José A
authors.initials: JA
authors.lastname: Román-Ivorra
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D013030:Spain; D016896:Treatment Outcome; D000079424:Tumor Necrosis Factor Inhibitors; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000079424:Tumor Necrosis Factor Inhibitors; C502936:tocilizumab
keywords: Artritis reumatoide; Disease-modifying antirheumatic drugs; Fármacos antirreumáticos modificadores de la enfermedad; Rheumatoid arthritis; Tocilizumab